Biological and Pharmaceutical Bulletin
Online ISSN : 1347-5215
Print ISSN : 0918-6158
ISSN-L : 0918-6158
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Particulate and Microbial Contamination in In-Use Admixed Parenteral Nutrition Solutions
Shigeharu OieAkira Kamiya
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2005 Volume 28 Issue 12 Pages 2268-2270

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Abstract

We evaluated particulate and microbial contamination in a total of 192 samples of in-use admixed and unadmixed parenteral nutrition solutions remaining in infusion bags in 10 hospitals. The mean numbers (range) of drug glass ampoules, plastic ampoules, and vials used in a total of 192 admixed solutions were 3.38 (1—13), 0.79 (0—7), and 1.2 (0—8), respectively. The mean number of particles (range) contained in the 192 samples according to the particle size (diameter) was 960.9 (30—9539)/ml for particles ≥1.3 μm, 42.8 (0—587)/ml for those ≥5 μm, 6.4 (0—146)/ml for those ≥10 μm, and 0.09 (0—1)/ml for those ≥50 μm. The number of particles ≥1.3 μm in diameter was significantly higher in the 192 samples than in 7 samples (controls) of solutions not mixed with any ampoule or vial (p<0.0001). In addition, the number of particles ≥1.3 μm in diameter was significantly higher in samples of solutions mixed with 4—13 glass ampoules than in those of solutions mixed with 1—3 glass ampoules (p<0.01). On the other hand, none of the 199 samples showed bacteria or fungi/5 ml residual solution. Measures against particulate contamination of admixed parenteral nutrition solutions are necessary.

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© 2005 The Pharmaceutical Society of Japan
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